GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry, patient table, oper

FDA device recall Z-0368-2011 · posted 2010-11-15 · Terminated

Recall details

Recalling firm: GE Healthcare, LLC
Reason for recall: GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems.
Action taken: An Urgent Medical Device Correction letter dated September 2, 2010 was sent to consignees beginning September 3, 2010. This letter addressed the LightSpeed VCT systems. Another Urgent Medical Device Correction letter, dated September 24, 2010 was sent September 24, 2010 for the BrightSpeed Systems. The letters described the issue and provided safety instructions for the health care provider to be aware if the table should stop unexpectedly and the x-ray remains on to manually stop the scan until the devices software is upgraded. If you have any questions, please contact the US (800) 437-1171, Japan 0120-055-919, Korea 1544-6119, Australia/New Zealand 800 659 465, China 800-810-8188; for other countries, please contact your local GE Healthcare Services Representative.
Root cause: Software design
Status: Terminated
Product code: JAK
Quantity affected: 68
Distribution: Worldwide distribution: USA including states of: MI, NM, OH, TX, and Puerto Rico and countries including: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Bra
Date initiated: 2010-09-03
Date posted: 2010-11-15
Date terminated: 2012-05-15
Location: Waukesha, WI

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
GE LIGHTSPEED 7.2 CT SCANNER SYSTEM (K082761)	Ge Medical Systems, LLC	2008-10-08
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM (K082816)	Ge Medical Systems, LLC	2008-10-08
STARSPEED SERIES CT SCANNER SYSTEMS (K052855)	GE Healthcare	2005-10-28